Encore Medical, LP Recalls Reverse Shoulder Prosthesis (RSP) Humeral Socket Inserts Due to Labeling Error
Encore Medical, LP has issued a voluntary recall for 20 units of its Reverse Shoulder Prosthesis (RSP) humeral socket inserts because of incorrect labeling.
What Happened
Encore Medical, LP, based in Austin, Texas, has initiated a voluntary recall of its Reverse Shoulder Prosthesis (RSP) humeral socket inserts. The recall was prompted by the discovery that certain knee and humeral socket implants contain incorrect labeling. This Class II recall was officially classified by the FDA on February 24, 2026.
Which Products Are Affected
The recall affects 20 implants with the following specifications:
- Brand Name: Reverse Shoulder Prosthesis (RSP)
- Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus
- Model/Catalog Number: 509-00-036
- Lot Code: 378P1382
- GTIN: 00888912144544
Distribution: The affected products were distributed to healthcare facilities in the following states: VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, and CA.
What You Should Do
Encore Medical, LP initiated the recall on January 15, 2026, by notifying affected customers via a formal letter. Healthcare providers and surgical facilities should immediately check their inventory for the affected lot code (378P1382). If the product is found, it should be quarantined and handled according to the instructions provided in the firm’s notification letter. For further information, facilities should contact Encore Medical, LP directly at their Austin, TX headquarters.
Why This Matters
Incorrect labeling on medical implants is a significant concern as it can lead to the selection of the wrong component during surgical procedures, potentially resulting in patient injury or the need for revision surgery.
Source
Information provided by the FDA. Recall Number: Z-1460-2026.
Source: FDA Official Notice